Objective-Few patients take inhaled corticosteroids as recommended. This study aimed to determine the effectiveness of school-based supervised asthma therapy in improving asthma control. The primary hypothesis was that the supervised asthma therapy group would have a lower proportion of children experiencing an episode of poor asthma control (EPAC) each month compared to the usual care group.Patients and Methods-Children were eligible if they had physician-diagnosed persistent asthma, the need for daily controller medication, and the ability to use a dry-powder inhaler and a PFM. The trial used a two-group randomized longitudinal design with 15 month follow-up. 290 children from 36 schools were randomly assigned to either: school-based supervised asthma therapy or usual care. Ninety-one percent of children were African American and 57% were male. Mean age was 11 years (SD = 2.1). An EPAC was defined as one or more of the following each month: 1) an absence from school due to respiratory illness/asthma; 2) average use of rescue medication more than two times per week (not including pre-exercise treatment); or 3) at least one red or yellow PFM reading.Results-240 children completed the study. There were no differences in the likelihood of an EPAC between the baseline and follow-up period in the usual care group (p=0.77); however, among those in the supervised therapy group, the odds of experiencing an EPAC during the baseline period were 1.57 times the odds of experiencing an EPAC during the follow-up period (90% CI: 1.20, 2.06, p=0.006). GEE modeling revealed a marginally significant interaction between the intervention and time period (p=0.065) indicating that children in the supervised therapy group showed greater improvement in asthma control.Conclusions-Supervised asthma therapy improves asthma control. Clinicians who have pediatric asthma patients with poor outcomes that may be due to non-adherence should consider supervised therapy.
Evidence from longitudinal cohort studies demonstrates that wheezing which begins in early life and continues into the school age years generally persists into adulthood. This persistent wheezing is associated with lung function deficits and airways hyperresponsiveness that appear to be established in the first few years of life. Allergic sensitization early in life, early life infection with rhinovirus, or colonization with any of a number of bacteria have been associated with increased risk of persistent wheeze. Early life, whether in utero or in the first few years of life, presents a window of vulnerability during which airway injury results in persistent airways dysfunction. Available data futher suggest that a second such window of vulnerability may be present in the preadolescent and adolescent years. Lung function growth patterns established by age 6 generally continue into early to mid-adulthood, typically leaving groups of individuals with wheezing that persists into or relapses in adulthood with mean FEV1 about 10% predicted lower than their peers who do not wheeze. Subgroups of patients with persistent asthma, however, may have progressive declines in lung function, and enter adulthood with even lower lung function. The concern exists that these deficits in lung function apparent in early adulthood may put individuals at risk for the later development of chronic obstructive pulmonary disease.
IMPORTANCE Soy isoflavone supplements are used to treat several chronic diseases, although the data supporting their use are limited. Some data suggest that supplementation with soy isoflavone may be an effective treatment for patients with poor asthma control.OBJECTIVE To determine whether a soy isoflavone supplement improves asthma control in adolescent and adult patients with poorly controlled disease. DESIGN, SETTING, AND PARTICIPANTS Multicenter, randomized, double-blind, placebo-controlled trial conducted between May 2010 and August 2012 at 19 adult and pediatric pulmonary and allergy centers in the American Lung Association Asthma Clinical Research Centers network. Three hundred eighty-six adults and children aged 12 years or older with symptomatic asthma while taking a controller medicine and low dietary soy intake were randomized, and 345 (89%) completed spirometry at week 24.INTERVENTIONS Participants were randomly assigned to receive soy isoflavone supplement containing 100 mg of total isoflavones (n=193) or matching placebo (n=193) in 2 divided doses administered daily for 24 weeks. MAIN OUTCOMES AND MEASURESThe primary outcome measure was change in forced expiratory volume in the first second (FEV 1 ) at 24 weeks. Secondary outcome measures were symptoms, episodes of poor asthma control, Asthma Control Test score (range, 5-25; higher scores indicate better control), and systemic and airway biomarkers of inflammation.RESULTS Mean changes in prebronchodilator FEV 1 over 24 weeks were 0.03 L (95% CI, −0.01 to 0.08 L) in the placebo group and 0.01 L (95% CI, −0.07 to 0.07 L) in the soy isoflavone group, which were not significantly different (P = .36). Mean changes in symptom scores on the Asthma Control Test (placebo, 1.98 [95% CI,] vs soy isoflavones, 2.20 [95% CI, 1.53-2.87]; positive values indicate a reduction in symptoms), number of episodes of poor asthma control (placebo, 3.3 [95% CI, 2.7-4.1] vs soy isoflavones, 3.0 [95% CI, 2.4-3.7]), and changes in exhaled nitric oxide (placebo, −3.48 ppb [95% CI, −5.99 to −0.97 ppb] vs soy isoflavones, 1.39 ppb [95% CI, −1.73 to 4.51 ppb]) did not significantly improve more with the soy isoflavone supplement than with placebo. Mean plasma genistein level increased from 4.87 ng/mL to 37.67 ng/mL (P < .001) in participants receiving the supplement.CONCLUSIONS AND RELEVANCE Among adults and children aged 12 years or older with poorly controlled asthma while taking a controller medication, use of a soy isoflavone supplement, compared with placebo, did not result in improved lung function or clinical outcomes. These findings suggest that this supplement should not be used for patients with poorly controlled asthma.
ABSTRACT. Objective. The purpose of this study was to validate a 3-stage asthma case-detection procedure for elementary school-aged children.Methods. The study was performed in 10 elementary schools in 4 inner-city school systems, with a total enrollment of 3539 children. Results of the case-detection procedure were compared with the diagnosis of an asthma specialist study physician, to determine the sensitivity and specificity of the case-detection procedure.Results. Ninety-eight percent of children returned the asthma symptoms questionnaires, and 79% of those children consented to additional testing. Results indicated that the 3-stage procedure had good validity, with sensitivity, specificity, and predictive value of 82%, 93%, and 93%, respectively. A 2-stage procedure using questionnaires and spirometry had similar validity, with sensitivity, specificity, and predictive value of 78%, 93%, and 93%, respectively. However, given the time and expense associated with the 2-or 3-stage procedure and the difficulty of obtaining physician follow-up evaluation of the case-detection diagnosis, schools may prefer to use a 2-item questionnaire that has a lower sensitivity (66%) but higher specificity (96%) and predictive value (95%).Conclusions. Case-detection programs are generally well received by school personnel and can identify children with unrecognized or undiagnosed disease, as well as those with a current diagnosis but poorly controlled disease. This study yields substantial information regarding the validity, yield, and specific types of children who might be identified with the use of such procedures. For the choice of the method of case detection used in a school, the strengths and weaknesses of each procedure, as well as the resources available for case detection, physician referral, and follow-up procedures, must be considered.
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